PK and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ICMJE (submitted: July 31, 2007)

Pharmacokinetics will be determined by serial measurements of its concentration in plasma

Efficacy will be determined by evidence of OR, PFS, and OS calculated from the start of treatment.

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Official Title ICMJE

A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Brief Summary

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.

Detailed Description

GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg.

Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle.

Study Arm (s)

Experimental: Single Arm Trial

Patients will be enrolled in the order of confirmation of eligibility. Dose cohorts will be filled sequentially with a minimum of 3 patients. Once assigned to a dose cohort, each patient will continue to be treated at the same dose level throughout the course of the study.

Intervention: Drug: Imetelstat Sodium (GRN163L)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

27

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of NSCLC

Stage IIIb with pleural effusion, Stage IV, or recurrent disease

Measurable or evaluable disease by RECIST criteria

ECOG performance status 0-1

Adequate hepatic/renal function and platelet count

If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%